Pfizer Reports Positive Data From Phase 3 Trial Of Talzenna/Xtandi Combo

(RTTNews) - Pfizer (PFE) Thursday reported positive results from the Phase 3 TALAPRO-2 study of Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide).

The results demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared to placebo plus Xtandi in men with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations.

In addition, the U.S. Food and Drug Administration (FDA) has granted priority review for Pfizer's supplemental new drug application (sNDA) for Talzenna in combination with Xtandi for the treatment of men with mCRPC.

he FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. The FDA's decision on the sNDA is expected in 2023.

In the final rPFS analysis, Talzenna plus Xtandi reduced the risk of disease progression or death by 37% versus placebo plus Xtandi. The median rPFS for the treatment arm was not reached at the time of analysis versus 21.9 months for placebo plus Xtandi. Median rPFS is reached when 50% of trial participants have had an event of disease progression or death.